1. Field of the Invention
In general, the present invention relates to devices and methods for compressing and insertion of a pliable prosthetic implant, such as a breast augmentation implant, and advancing the prosthetic implant through a small diameter incision during a surgical procedure in a manner to reduce the risk of infection.
2. Prior Art Description
Breast augmentation surgery that utilizes breast implants has been widely practiced by surgeons for decades. In this period or time, the implants, techniques, and instruments used during the surgery have continued to evolve. The results are patients that required less time under anesthetic, patents having smaller incisions, improved feel of the implant simulating indigenous tissue and patients having more natural appearing and results.
In a modern breast augmentation procedure, a small incision is made in or near the breast. A breast implant is then deformed through the small incision and into the surgical pocket beneath the breast tissue. This is typically accomplished by the surgeon manipulating the implant through the incision in direct contact with the patient's tissue or placement via an insertion instrument, such as a sleeve as originally described by Mladick in “Twelve Months of Experience with Bioplastique”, Aesth. Plast. Surg., 16: 69-76, 1992, or a modification of the sleeve such as a funnel as described by Keller and others (patents cited below). Such funnels are little more than conical tubes, such as those used for cake decorating. The implant is placed into the large end of the funnel. The small end of the funnel is then placed in the incision. The implant is forced through the funnel and into the incision by continually squeezing and compressing the funnel. Such prior art funnel systems are exemplified by U.S. Patent Application Publication No. 2009/0204107, entitled “Apparatus and Process for Delivering a Silicone Prosthesis into a Surgical Pocket”; U.S. Patent Application Publication No. 2010/0280610, entitled “Silicone Breast Implant Delivery;” U.S. Patent Application Publication No. 2011/0035003, entitled “Fail-safe Silicone Breast Implant Delivery Device”; and U.S. Pat. No. 8,550,090 to Keller, entitled Apparatus And Process For Delivering A Silicone Prosthesis into A Surgical Pocket.
U.S. Pat. No. 8,641,758 to Anderson, entitled Method And Apparatus For Inserting A Filled Prosthetic Bladder Into A Patient, discloses a funnel shaped instrument that deforms a pliable prosthetic implant into a small incision. However, due to the funnel shape, the device has the same disadvantages as prior art funnel-shaped compression bags.
The use of prior art funnels, sleeves, or other systems has both advantages and disadvantages. The advantages of a prior art funnel, sleeve, or other system include the fact that the use of the funnel, sleeve, or other system only requires a small incision to be made in the breast. Furthermore, when an implant is used, the implant only touches the sterile interior of the funnel, sleeve, or other system as it is being advanced into the body. This “no-touch” system minimizes contamination issues and the occurrence of capsular contracture due to contamination.
The specific disadvantages of using a funnel include the fact that the implant is forced into a conical shape as it conforms to the interior of the funnel. This conical shape is analogous to the shape of a cork stopper in a bottle. This conical shape is then physically forced though the small exit diameter of the funnel. A large amount of force is required to advance the implant in the funnel. This force is applied manually by the surgeon. To achieve the needed force, the surgeon must often wind and crumple the funnel. This can damage the implant, particularly the shell, if the implant gets caught in a fold of the crumple. The build-up of forces can also cause permanent bulges in the shell of the implant, which adversely affects the aesthetics of the implant. Furthermore, the force applied by the surgeon builds until the implant suddenly ejects from the funnel and into the tissue of the breast at an uncontrolled rate which is a particularly difficult to monitor due to the opaque nature of the funnel. This makes it nearly impossible to visualize damage or proper orientation of the implant as it is ejected from the funnel or other sleeve like devices. This can cause unnecessary bruising and tearing of tissue both inside the breast and at the incision. If proper orientation of the implant cannot be achieved by happenstance as it is ejected from the device, the surgeon must typically manipulate the implant thereby negating the “no touch” technique. The potential for microbial contamination is thus increased.
A need therefore exists for an improved system that can be used during a breast augmentation procedure, wherein the benefits of prior art funnel, sleeve, or other systems are maintained, but many of the disadvantages associated with funnels are eliminated or minimized. This need is met by the present invention as described and claimed below.